Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad de La Frontera
About this trial
CO-CREATION-HF aims to evaluate the effectiveness of a comprehensive and hybrid cardiac rehabilitation model compared to supervised exercise alone.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients with HF of New York Heart Association functional class II or III.
Meets HF diagnostic criteria of Guidelines
On optimal tolerated medical therapy.
Deemed by the treating physician as stable for at least 1 month.
Disqualifiers
Chronic kidney disease with glomerular filtration rate < 20 mL/min.
Decompensated thyroid disease.
End-stage liver failure or Child-Pugh C.
Cardiac device or cardiac surgery in the previous month or planned in the next 3 months.
Trial design
Design model
Parallel
Treatments tested in this trial
Comprehensive Initial Assessment
Other interventionInitial Assessment includes all those necessary to prescribe exercise training, as well as dietary and adherence promotion interventions. * Functional capacity with 6MWT * Assessment of skeletal muscle strength, flexibility, and balance. * Assessment of function * Assessment of dietary habits * Assessment of self-efficacy and barriers to CR adherence. * Screening for depression.
Continuous evaluation
Other interventionEvaluations during the course of the program will be carried out to inform the progression through the CR stages, the intensity of training and education needs.
Interval Exercise
Other interventionHigh-intensity interval training prescribed by physical therapist: * According to an adapted Wisloff protocol. * Borg scale to monitor intensity. * Training 3 times per week.
Psychosocial support
BehavioralBased on social-cognitive theory, with self-efficacy as a focus: * Face-to-face sessions in the first stage of the program: Education, self-monitoring and motivational interview. * Face-to-face session in the second stage of the program: promoting behavior changes by self-control and self-monitoring * Regular communication with patients will be supported by the use of mobile devices during the third and fourth stages of program.
Diet management
Other interventionA dietary plan supported by a nutritionist will be made together with the patient.
Resistance exercise
Other interventionResistance exercises: * With TheraBand. * Intensity according to the perceived exertion scale * Twice a week.
Continuous exercise
Other interventionModerate-intensity continuous exercise prescribed by physical therapist : * The intensity will be moderate, as tolerated * Borg scale to monitor intensity. * Frequency of training of 1 to 3 times per week, until completed 20 sessions in 10-12 weeks.
Initial Assessment
Other interventionIncludes all those necessary to plan exercise training, as usual: * Functional capacity with 6MWT. * Assessment of skeletal muscle strength.
Treatment groups
152 Participants
are divided into 2 treatment groupsGroup A: Comprehensive Hybrid Cardiac RehabilitationExperimental treatment 6 interventions
Group B: Exercise and center-based Cardiac RehabilitationActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
Cardiorespiratory fitness
Will be assessed during a symptom-limited cardiopulmonary exercise test using an individualized gradual incremental ramp test designed to obtain oxygen consumption (VO2max).
Time frame
Baseline, 6 months and 12 months.2
Functional capacity
Will be assessed by the six-minute walk test (6MWT)
Time frame
Baseline, 6 months and 12 months.3
Health Related Quality of Life
Will be evaluated with the Minnesota Living with Heart Failure Questionnaire (MLHFQ). This questionnaire has 21 questions, which are answered on a scale of 1 to 5. The score of the questionnaire is obtained by the sum of the answers to the 21 questions, the higher the score, the worse the quality of life.
Time frame
Baseline, 6 months and 12 months.Secondary outcomes
1
Program adherence and completion
Program adherence is defined as the percentage of total prescribed sessions completed. For home-based activities, the percentage of activities carried out at home of the prescribed ones will be computed.
Time frame
6 months2
Concentration of Pro-B-type Natriuretic Peptide
Biomarker with prognostic utility. When it is higher than 1000 pg/mL, there is a higher probability of having events such as hospitalizations.
Time frame
Baseline, 6 months and 12 months.3
Functioning
Defined as the ability to perform basic, instrumental and advanced activities of daily living. It will be measured with the Activities of Daily Living Questionnaire - Technology (ADLQ-T). This questionnaire evaluates 7 areas: self-care (6 items), home care and management (6 items), work and recreation (4 items), shopping and money (3 items), travel (3), communication (5 items) and technology (5 items). Each item has a score, where 0 is no problem for the activity up to 3 indicating that he/she cannot perform the activity. The functional deficit is calculated for each area and for the overall questionnaire with the sum of all scores, divided by 3 and then multiplied by the total number of items answered. A higher score indicates greater impairment of ADLs.
Time frame
Baseline, 6 months and 12 months.4
Mortality and Hospital admission
Will be measured as a composite outcome. It will be measured as a composite outcome. An adjudicating committee will confirm the events that will be expressed as the number of participants hospitalized or dead and their respective causes. All-cause and HF-specific mortality and hospitalization will be differentiated.
Time frame
12 monthsSponsors and contacts
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Universidad de La Frontera
Lead sponsor
University of Chile
Collaborator
Source ClinicalTrials.gov